Medical Devices Registration in Philippines

Government Authority

In the Philippines, oversight of medical device registration falls under the jurisdiction of the Center for Device Regulation, Radiation Health, and Research (CDRRHR) within the Department of Health. (AMDD) ASEAN Medical Device Directive provided the list of documents needed for the registration of Medical Devices as per the Classification.

The documents required for LTO for a medical device importer/distributor are:

• Business Registration Certificate
• Location Plan
• Contract of lease of Space
• Pharmacist Information
• Product Listing
• Floor Plan
• Agreement with Medical Device Manufacturer for Distribution

Time frame to obtain the LTO is between 1 – 3 months.

To facilitate this process, the PFDA requires the following documentation (General) for review:

• ISO 13485
• Free Sale Certificate from Country of Origin
• Device Description
• Features
• Indications
• Instruction for use
• Pre-Clinical Studies
• Clinical Studies
• Shelf Life and Biocompatibility
• Label
• Risk Analysis
• A brief summary of the sterilization method
• Manufacturing Process

The current product classifications in the Philippines adhere to the ASEAN Medical Devices Directive, with categorizations ranging from low to high risk (Classes A, B, C, and D). The review time and registration fees vary according to the risk level. It’s important to note that In Vitro Diagnostic (IVD) devices have separate regulatory requirements under an upcoming Administrative Order.